Medtronic Guidewire Recall Categorized by FDA as Class I
Federal health officials indicate that problems with Medtronic guidewires used during cardiac procedures could pose a risk of serious injury or death, categorizing a recent recall as a Class I Medical Device recall due to the risk that a coating on the guidewires could break off and block blood vessels.
Medtronic Inc. announced a voluntary recall for about 15,000 guidewire devices on October 21, after at least four complaints were received, including one report where a patient went into cardiac arrest.
On November 15, the FDA announced that the Medtronic guidewire recall has received the most serious classification suggesting that continued use of the medical device may carry a reasonable probability or serious adverse health consequences or death.
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Guidewire devices are thin and flexible wires that are used during medical procedures to guide other stiff or bulkier instruments into place, such as catheters and stents. The recalled Medtronic guidewires have a coating on the outside that allows them to comfortably slide through blood vessels.
The specific guidewires devices impacted in this recall are used for placement of the left ventricular leads for cardiac rhythm devices, and were manufactured in the middle of April 2013. Products affected by this recall include the Cougar nitinol workhorse guidewire, Cougar steerable guidewire, Zinger stainless steel workhorse guidewire, Zinger steerable guidewire, Thunder extra-support guidewire, Thunder steerable guidewire, ProVia crossing guidewire, and the Attain Hybrid guidewire. For a full list recalled products and corresponding lot numbers please visit http://www.medtronic.com/for-healthcare-professionals/index.htm1.
During the initial recall in October, Medtronic began notifying hospitals and distributors worldwide of the potentially affected units and requested they be quarantined and returned to the company immediately for a full refund or credit. Healthcare professionals and patients may contact Medtronic Inc. at 1-877-526-7890 or by visiting them online at www.medtronic.com.
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